FDA 510(k)

CustMBite 牙齒保護器

K 號：K183315 · 2019-08-23

決定日期2019-08-23

產品代碼OBR

決定相當於

器材摘要

CustMBite Dental Guard is the device name listed in this FDA 510(k) record. The listed applicant is Dental Choice Holdings, LLC. It received FDA 510(k) clearance on 2019-08-23 under 510(k) number K183315. The device is classified under product code OBR. Product code OBR falls under the category of Orthopedic, which includes orthopedic implants, fixation devices, and surgical instruments. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

常見問題

What is the CustMBite Dental Guard?

CustMBite Dental Guard is a medical device that received FDA 510(k) clearance on 2019-08-23. The listed applicant is Dental Choice Holdings, LLC. The 510(k) number is K183315.

When did CustMBite Dental Guard receive FDA 510(k) clearance?

CustMBite Dental Guard received FDA 510(k) clearance on 2019-08-23, under 510(k) number K183315.

Who is the listed applicant for CustMBite Dental Guard?

The FDA 510(k) record lists Dental Choice Holdings, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CustMBite Dental Guard?

The FDA product code for CustMBite Dental Guard is OBR. This falls under the Orthopedic category.

其他以 Dental Choice Holdings, LLC 為申請人之記錄

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K221322CUSTMBITE 噪鼾系統

相關器械（代碼：OBR）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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官方來源

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